trial investigating the long term safety and tolerability of desmopressin orally disintegrating tablets (odt) for nocturia due to nocturnal polyuria in japanese subjects

Conditions: Nocturia

Summary: demonstrate the safety and tolerability of desmopressin odt during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year


Eligibility criteria:
inclusion criteria (for subjects who participated in trials 000129 or 000130): * written informed consent prior to performance of any trial-related activity for the 000131 trial * has completed participation in trial 000129 or 000130 exclusion criteria (for subjects who participated in trials 000129 or 000130): * hyponatraemia (serum sodium level \<135 mmol/l) at visit 7 in trial 000129 or 000130 * withdrawal from clinical trial 000129 or 000130 inclusion criteria (for subjects who did not participate in trials 000129 or 000130): * written informed consent prior to performance of any trial-related activity * adult ≥20 years of age * nocturia symptoms present for ≥6 months prior to trial entry at visit 1a * nocturnal polyuria at the end of screening period prior to visit 1b * bothered by nocturia on the hsu 5-point likert bother scale at visit 1a and visit 1b * has given agreement about contraception during the trial exclusion criteria (for subjects who did not participate in trials 000129 or 000130): * early withdrawal from clinical trial 000129 or 000130 * evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to visit 1b * history or evidence of significant obstructive sleep apnoea * history or diagnosis of any of the following urological diseases: * interstitial cystitis or bladder pain disorder * in males, suspicion of moderate or severe benign prostate hyperplasia (bph), defined as international prostate symptom score (ipss) ≥8 points and: * urinary flow \<5 ml/s or * post-void residual volume \>150 ml * stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history * chronic prostatitis/chronic pelvic pain syndrome * surgical treatment, including transurethral resection, for boo or bph within the past 6 months prior to visit 1a * symptoms of severe over-active bladder (oab): * defined as an over-active bladder symptom score (oabss) ≥12 at visit 1a * defined as a mean of \>8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to visit 1b * genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at visit 1a * complication of cancer or a history of cancer which has not been in remission for the last 5 years at visit 1a * current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at visit 1a * history of any neurological disease affecting bladder function or muscle strength at visit 1a * habitual or psychogenic polydipsia based on medical history at visit 1a or 24-hour urine output of \>2.8 l based on the voiding diary at visit 1b * central or nephrogenic diabetes insipidus at visit 1a * syndrome of inappropriate antidiuretic hormone secretion at visit 1a * suspicion or evidence of cardiac failure at visit 1a * uncontrolled hypertension at visit 1a and visit 1b * hyponatraemia (serum sodium level \<135 mmol/l) at visit 1a renal insufficiency at visit 1a and visit 1b * renal insufficiency at visit 1a and visit 1b * hepatic and/or biliary diseases at visit 1a and visit 1b * known or suspected hypersensitivity to desmopressin odts or previous desmopressin treatment for nocturia at visit 1a * in females, pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. * known alcohol or substance abuse at visit 1a * work or lifestyle that may interfere with regular night-time sleep at visit 1a, e.g., shift workers * any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at visit 1a * use of any prohibited therapy during the trial period